Post Operative Sore Throat and Dexamethasone

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Sore Throat; Pain

Treatments: Drug: Dexamethasone 0.05mg/kr administration; Drug: Dexamethasone 0.1mg/kg; Drug: Placebo administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01052038

STU00018901

Details and patient eligibility

About

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery.

Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics. The preoperative administration of dexamethasone can decrease the incidence and severity of postoperative sore throat which is rated by patients as one of the most undesirable outcomes in the postoperative period.

Full description

Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction. The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery. It has been observed that gargle with azunol reduced the incidence of postoperative sore throat from 65% to 25 %. Similarly, a reduction in sore throat following tracheal intubation from 78% to 40 % has been reported after gargle with ketamine performed 5 minutes before induction of anesthesia. More recently, it was also demonstrated that preoperative gargle with licorice resulted in a 57 percent reduction of the absolute risk of sore throat after intubation. Although the gargling technique has been shown to be successful in decreasing the incidence of postoperative sore throat, it has a limited feasibility because the volumes administered could increase the chance of aspiration if ingested and it may be difficult to perform in sedated patients and in children.

Tracheal intubation is associated with an increase of polymorphonuclear cells in the tracheal tissue and plasma levels of interleukin 6, suggesting an inflammatory response to the presence of the endotracheal tube itself or to some aspect of the intubation process. Dexamethasone is widely prescribed for the treatment of a sore throat resulting from tracheal mechanical irritation due to its modulating effects of tissue edema and pain. Moreover, prophylactic dexamethasone has been shown to be effective in reducing the frequency of airway obstruction in patients at high risk for laryngeal edema following extubation. It decreases postoperative sore throat in patients requiring double-lumen tubes.

Dexamethasone has been shown to decrease postoperative sore throat in patients requiring hospital admission but it has not been evaluated in the ambulatory setting. Ambulatory patients usually need to return to work faster than patients who are admitted to the hospital. Their ability to tolerate fluids and food might help them to return to normal living. They also have smaller surgeries which might increased their perception to sore throat pain when compared to bigger, more painful procedures.

Possible side effects of corticosteroids such as retardation of wound healing, susceptibility to infection and gastrointestinal hemorrhage have not been noted with short term use (<24 hours ) in surgical patients. Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients undergoing outpatient laparoscopic gynecologic surgery
• ASA PS I and II
• Age between 18 and 64 years
• Fluent in English

Exclusion criteria

• History of recent respiratory tract infection
• Pregnancy, breastfeeding
• Current treatment with analgesics
• Current use of corticosteroids
• Anticipated difficult intubation
• Risk factors for post-operative aspiration

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Group 1 Placebo

Placebo Comparator group

Description:

Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.

Treatment:

Drug: Placebo administration

Group 2: Dexamethasone 0.05mg/kg

Active Comparator group

Description:

Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery

Treatment:

Drug: Dexamethasone 0.05mg/kr administration

Group 3:Dexamethasone 0.1mg/kg

Active Comparator group

Description:

Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.

Treatment:

Drug: Dexamethasone 0.1mg/kg